Planning Your (First) First-in Human Trial? Considerations for Success - Xtalks
Clinical trial phases, requirements and regulations
Pharmacokinetics of ASP4345 from Single Ascending-Dose and Multiple Ascending-Dose Phase I Studies | SpringerLink
ONCE-DAILY REGIMENS OF THE HCV NS3/4A-PROTEASE INHIBITOR TMC435350 ARE PREDICTED TO PROVIDE THERAPEUTIC EXPOSURE IN PLASMA AND LIVER
Accelerating the transition of new tuberculosis drug combinations from Phase II to Phase III trials: New technologies and innovative designs | PLOS Medicine
Phase I Trial of Anti–Vascular Endothelial Growth Factor/Anti-angiopoietin 2 Bispecific Antibody RG7716 for Neovascular Age-Related Macular Degeneration - Ophthalmology Retina
Phase 1a Randomized Double-Blind Placebo-Controlled Single-Ascending Dose and Multiple-Ascending Dose Studies of Orally Inhaled GB002 in Healthy Adult Subjects - Gossamer Bio
A Guide to Phase 1 Clinical Trial Designs
Safety, pharmacokinetics, and antimalarial activity of the novel plasmodium eukaryotic translation elongation factor 2 inhibitor M5717: a first-in-human, randomised, placebo-controlled, double-blind, single ascending dose study and volunteer infection ...
Study design. The study included single and multiple ascending... | Download Scientific Diagram
Single and Multiple Ascending-dose Studies of Oral Delafloxacin: Effects of Food, Sex, and Age - ScienceDirect
Statistical considerations in exploratory studies
The phases of preclinical and clinical trials
A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers | BMC Pulmonary
CR Tidbit – SAD MAD Studies | AuroBlog | Clinical Research Blog | Aurous HealthCare CRO, India
Schematic of the ECG timepoints and meals in the single-ascending dose... | Download Scientific Diagram
The phases of preclinical and clinical trials
A Flow-chart of the single-ascending-dose (SAD) and... | Download Scientific Diagram
Phase I: Overview
Traditional Process First in Human Single Ascending Dose Multiple Ascending Dose U.S.A. Japan Phase II Phase III NDA in Japan Phase II Phase III NDA in. - ppt download
Single- and Multiple-Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics of the Polymyxin Derivative SPR206 | Antimicrobial Agents and Chemotherapy
